Effects of liposomal bupivacaine on opioid use and healthcare resource utilization after outpatient spine surgery: a real-world assessment.

BACKGROUND CONTEXT: Perioperative pain management affects cost and outcomes in elective spine surgery. PURPOSE: This study investigated the association between liposomal bupivacaine (LB) and outpatient spine surgery outcomes, including perioperative, postoperative, and postdischarge opioid use and healthcare resource utilization. STUDY DESIGN: This was a retrospective comparative study. PATIENT SAMPLE: Eligibility criteria included adults with ≥6 months of continuous data before and after outpatient spine procedures including discectomy, laminectomy, or lumbar fusion. Patients receiving LB were matched 1:3 to patients receiving non-LB analgesia by propensity scores. OUTCOME MEASURES: Outcomes included (1) opioid use in morphine milligram equivalents (MMEs) during the perioperative and postdischarge periods and (2) postdischarge readmission and emergency department (ED) visits up to 3 months after surgery. Generalized linear mixed-effects modeling with appropriate distributions was used for analysis. METHODS: Deidentified data from the IQVIA linkage claims databases (2016-2019) were used for the analysis. This study was funded by Pacira BioSciences, Inc. RESULTS: In total, 381 patients received LB and 1143 patients received non-LB analgesia. Baseline characteristics were well balanced after propensity score matching. The LB cohort used fewer MMEs versus the non-LB cohort before discharge (80 vs 132 MMEs [mean difference, -52 MMEs; p=.0041]). Following discharge, there was a nonsignificant reduction in opioid use in the LB cohort versus the non-LB cohort within 90 days (429 vs 480 MMEs [mean difference, -50 MMEs; p=.289]) and from >90 days to 180 days (349 vs 381 MMEs [mean difference, -31 MMEs; p=.507]). The LB cohort had significantly lower rates of ED visits at 2 months after discharge versus the non-LB cohort (3.9% vs 7.6% [odds ratio, 0.50; p=.015]). Postdischarge readmission rates did not differ between cohorts. CONCLUSIONS: Use of LB for outpatient spine surgery was associated with reduced opioid use at the hospital and nonsignificant reduction in opioid use at all postoperative timepoints examined through 90 days after surgery versus non-LB analgesia. ED visit rates were significantly lower at 60 days after discharge. These findings support reduced cost and improved quality metrics in patients treated with LB versus non-LB analgesia for outpatient spine surgery.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSE: To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGN: Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURES: The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODS: Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTS: At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONS: Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

The Outcomes of Revision Anterior Cervical Decompression and Fusion Using a Stand-Alone Implant Versus Traditional Interbody Polyetheretherketone Cage, Titanium Plate, and Screw Instrumentation.

INTRODUCTION: Anterior cervical decompression and fusion (ACDF) is the standard surgical procedure for cervical radiculopathy and myelopathy, although ACDF includes risks of adjacent segment disease (ASD) and subsequent revision procedures. Various interbody cage, plate, and screw options can be utilized. Stand-alone devices were designed to overcome undesired complications of hardware prominence and associated dysphagia, soft tissue violation, and adjacent level encroachment. Implants include biomechanical structural support (cage) composed of various materials (polyetheretherketone (PEEK)/titanium) and integral fixation (screws/blades). The purpose was to compare intraoperative, short- and long-term outcomes of revision ACDF using a stand-alone implant (ACDF-ZP group) versus traditional interbody PEEK cage, titanium plate, and screw instrumentation (ACDF-CP group). METHODS: This was a retrospective, cohort study reviewing charts of patients who underwent revision ACDF. The primary outcome measure was the incidence of postoperative dysphagia. Secondary outcomes included intraoperative, short-term, and long-term outcomes and complications. RESULTS: Sixty-one patients were included (ACDF-ZP group = 50; ACDF-CP group = 11). In-hospital incidence of dysphagia was significantly less in the ACDF-CP group (P = 0.041). Thrity-one (62.0%) of the ACDF-ZP group reported dysphagia postoperatively, half resolved by 6 weeks, and two persisted for more than 6 months. Five (45.5%) of the ACDF-CP group reported dysphagia with most resolving within 6 weeks. There were no statistically significant differences between groups in short- or long-term complications, dysphonia, or reoperation rates. No statistical significance was seen in blood loss, operative time, hospital stay, local and global alignment, or cage subsidence. CONCLUSION: Rates of dysphagia were comparable between groups at short and long-term follow-up, despite a greater incidence of postoperative dysphagia in the ACDF-ZP group. All complications and occurrences of cage subsidence were observed in the ACDF-ZP group, which may be attributed to the larger sample size. Given these findings, zero-profile stand-alone implants and traditional interbody PEEK cage, titanium plate, and screw instrumentation appear to be both safe and effective options for revision ACDF.

Longitudinal Assessment of Modern Spine Surgery Training: 10-Year Follow-up of a Nationwide Survey of Residency and Spine Fellowship Program Directors.

Spine surgeons complete training through residency in orthopaedic surgery (ORTH) or neurosurgery (NSGY). A survey was conducted in 2013 to evaluate spine surgery training. Over the past decade, advances in surgical techniques and the changing dynamics in fellowship training may have affected training and program director (PD) perceptions may have shifted. Methods: This study is a cross-sectional survey distributed to all PDs of ORTH and NSGY residencies and spine fellowships in the United States. Participants were queried regarding characteristics of their program, ideal characteristics of residency training, and opinions regarding the current training environment. χ2 tests were used to compare answers over the years. Results: In total, 241 PDs completed the survey. From 2013 to 2023, NSGY increased the proportion of residents with >300 spine cases (86%-100%) while ORTH remained with >90% of residents with < 225 cases (p < 0.05). A greater number of NSGY PDs encouraged spine fellowship even for community spine surgery practice (0% in 2013 vs. 14% in 2023, p < 0.05), which continued to be significantly different from ORTH PDs (∼88% agreed, p > 0.05). 100% of NSGY PDs remained confident in their residents performing spine surgery, whereas ORTH confidence significantly decreased from 43% in 2013 to 25% in 2023 (p < 0.05). For spinal deformity, orthopaedic PDs (92%), NSGY PDs (96%), and fellowship directors (95%), all agreed that a spine fellowship should be pursued (p = 0.99). In both 2013 and 2023, approximately 44% were satisfied with the spine training model in the United States. In 2013, 24% of all PDs believed we should have a dedicated spine residency, which increased to 39% in 2023 (fellowship: 57%, ORTH: 38%, NSGY: 21%) (p < 0.05). Conclusion: Spine surgery training continues to evolve, yet ORTH and neurological surgery training remains significantly different in case volumes and educational strengths. In both 2013 and 2023, less than 50% of PDs were satisfied with the current spine surgery training model, and a growing minority believe that spine surgery should have its own residency training pathway. Level of Evidence: IV.

The effectiveness of pre-contoured titanium alloy rods in inducing thoracic kyphosis after sequential spinal releases in an in vitro biomechanical model.

Purpose: Evaluate the ability of pre-contoured rods to induce thoracic kyphosis (TK) in human cadaveric spines and determine the effectiveness of sequential surgical adolescent idiopathic scoliosis (AIS) release procedures. Methods: Six thoracolumbar (T3-L2) spine specimens were instrumented with pedicle screws bilaterally (T4-T12). Over correction using pre-contoured rods was performed for intact condition and Cobb angle was measured. Rod radius of curvature (RoC) was measured pre- and post-reduction. The process was repeated following sequential release procedures of (1) interspinous and supraspinous ligaments (ISL); (2) ligamentum flavum; (3) Ponte osteotomy; (4) posterior longitudinal ligament (PLL); and (5) transforaminal discectomy. Cobb measurements determined the effective contribution of release on TK and RoC data displayed effects of reduction to the rods. Results: The intact TK (T4-12) was 38.0° and increased to 51.7° with rod reduction and over correction. Each release resulted in 5°-7°of additional kyphosis; the largest releases were ISL and PLL. All releases resulted in significant increases in kyphosis compared to intact with rod reduction and over correction. Regionally, kyphosis increased ∼2° for each region following successive releases. Comparing RoC before and after reduction showed significant 6° loss in rod curvature independent of release type. Conclusion: Kyphosis increased in the thoracic spine using pre-contoured and over corrected rods. Subsequent posterior releases provided a substantial, meaningful clinical change in the ability to induce additional kyphosis. Regardless of the number of releases, the ability of the rods to induce and over correct kyphosis was reduced following reduction.

Bridging the Cervicothoracic Junction During Multi-Level Posterior Cervical Decompression and Fusion: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review and Meta-analysis. OBJECTIVE: This systematic review seeks to compare fusion, reoperation and complication rates, estimated blood loss (EBL), and surgical time between multi-level instrumented fusions with LIVs (lowest instrumented vertebra) in the cervical spine and those that extend into the thoracic spine. SUMMARY OF BACKGROUND DATA: Several studies address the question of whether to extend a long-segment, posterior cervical fusions, performed for degenerative disease, into the upper thoracic spine. Recommendations for appropriate LIV continue to vary. METHODS: A comprehensive computerized literature search through multiple electronic databases without date limits up until April 3rd, 2020 using combinations of key search terms and sets of inclusion/exclusion criteria was performed. RESULTS: Our comprehensive literature search yielded 3852 studies. Of these, 8 articles consisting of 1162 patients were included in the meta-analysis. In 61.2% of the patients, the fusion did not cross the cervicothoracic junction (CTJ) (cervical LIV, CLV). In the remaining 38.8%, the fusion extended into the upper thoracic spine (thoracic LIV, TLV). Overall, mean patient age was 62.5 years (range: 58.8-66.1 years). Our direct analysis showed that odds of fusion were not statistically different between the CLV and TLV groups (OR: .648, 95% CI: .336-1.252, P = .197). Similarly, odds of reoperation (OR: 0.726, 95% CI: 0.493-1.068, P = .104) and complication rates were similar between the 2 groups (OR: 1.214, 95% CI: 0.0.750-1.965, P = .430). Standardized mean difference (SMD) for the blood loss (SMD: .728, 95% CI: 0.554-.901, P = .000) and operative (SMD: 0.653, 95% CI: .479-.826, P = .000) differed significantly between the 2 groups. The indirect analysis showed similar fusion (Effect Size (ES)TLV: .892, 95% CI: .840-.928 vs ESCLV:0.894, 95% CI:0.849-.926); reoperation rate (ESTLV:0.112, 95% CI: 0.075-.164 vs ESCLV: .125, 95% CI: .071-.211) and complication rates (ESTLV: .108, 95% CI: .074-.154 vs ESCLV:0.081, 95% CI: .040-.156). CONCLUSIONS: Our meta-analysis showed that fusion, complication, and reoperation rates did not differ significantly between patients in whom multi-level posterior fusions ended in the cervical spine vs those of which was extended into the thoracic spine. The mean blood loss, operative time and length of stay were significantly lower in patients with CLV at C6 or C7, compared to their counterparts. These data suggest that, absent focal, C7-T1 pathology, extension of long, posterior cervical fusions into the thoracic spine may not be necessary.

CT based bone mineral density as a predictor of proximal junctional fractures.

Background: Proximal junctional fractures (PJFr) can be a catastrophic complication associated with adult spinal deformity surgery. Osteoporosis can be a major risk factor for the cause of PJFr. Recent studies suggest using surrogate computed tomography (CT) scans in place of spinal dual-energy x-ray absorptiometry (DEXA) scores for bone mineral density (BMD). Investigate the feasibility of using preoperative CT based bone mineral density at upper instrumented vertebrae (UIV) and one level proximally (UIV+1) and distally (UIV-1) to predict the possibility of PJFr risk. Methods: Retrospective two-academic center case-controlled study, reviewed consecutive adult spinal deformity surgeries; included constructs encompassing at least five fusion levels and fusions to pelvis. Examined demographic, surgical, and radiographic data preoperatively, postoperatively, and final follow-up. Formed groups based on type of proximal junctional deformity (PJD): Control (no PJD), proximal junctional kyphosis (PJK) and PJFr. Preoperative CT BMD values measured in Hounsfield units (HU) for sagittal and axial planes at UIV, UIV+1, and UIV-1 and compared between groups. Results: N=92 patients. Preoperative CT scan BMD values were significantly lower in PJFr vs. control at: UIV+1 in sagittal (p=0.007), axial (p=0.02) planes; UIV sagittal (p=0.04) and axial (p=0.03) planes; and UIV-1 sagittal (p=0.05) plane. Similarly, lower CT scan BMD values noted in PJFr vs. PJK at: UIV+1 in sagittal (p=0.04) and axial (p=0.03) planes. Trend seen with lower CT scan BMD values at UIV+1 level in PJFr vs. PJK in sagittal (p=0.12) and axial (p=0.10) planes. Preoperative global sagittal imbalance measurements significantly lower in control, but comparable between PJK and PJFr. Conclusions: Higher preoperative global sagittal imbalance with lower preoperative CT BMD values at UIV and UIV+1 vertebral body may increase the risk of proximal junctional fractures after adult spine deformity surgery. Proximal junctional hooks may supplement the pathogenesis. Readers should note the small sample size.Level of Evidence: 3.

Spinal deformity surgery is accompanied by serious complications: report from the Morbidity and Mortality Database of the Scoliosis Research Society from 2013 to 2020.

PURPOSE: The Morbidity and Mortality (M&M) report of the Scoliosis Research Society (SRS) has been collected since 1965 and since 1968 submission of complications has been required of all members. Since 2009, the SRS has collected information on death, blindness, and neurological deficit, with acute infection being added in 2012 and unintentional return to the operating room (OR) being added in 2017. In this report, we use the most recent data submitted to the SRS M&M database to determine the rate of neurological deficit, blindness, acute infection, unintentional return to the OR, and death, while also comparing this information to previous reports. METHODS: The SRS M&M database was queried for all cases from 2013 to 2020. The rates of death, vision loss, neurological deficit, acute infection, and unintentional return to the OR were then calculated and analyzed. The rates were compared to previously published data if available. Differences in complication rates between years were analyzed with Poisson regression with significance set at α = 0.05. RESULTS: The total number of cases submitted per year varied with a maximum of 49,615 in 2018 and a minimum of 40,464 in 2020. The overall reported complication rate from 2013 to 2020 was 2.86%. The overall mortality rate ranged from 0.09% in 2018 to 0.14% in 2015. The number of patients with visual impairment ranged from 4 to 13 between 2013 and 2015 (no data on visual impairment were collected after 2015). The overall infection rate varied from 0.95 in 2020 to 1.30% in 2015. When the infection rate was analyzed based on spinal deformity group, the neuromuscular scoliosis group consistently had the highest infection rate ranging from 3.24 to 3.94%. The overall neurological deficit rate ranged from 0.74 to 0.94%, with the congenital kyphosis and dysplastic spondylolisthesis groups having the highest rates. The rates of unintentional return to the OR ranged from 1.60 to 1.79%. Multiple groups showed a statistically significant decreasing trend for infection, return to the operating room, neurologic deficit, and death. CONCLUSIONS: Neuromuscular scoliosis had the highest infection rate among all spinal deformity groups. Congenital kyphosis and dysplastic spondylolisthesis had the highest rate of neurological deficit postoperatively. This is similar to previously published data. Contrary to previous reports, neuromuscular scoliosis did not have the highest annual death rate. Multiple groups showed a statistically significant decreasing trend in complication rates during the reporting period, with only mortality in degenerative spondylolisthesis significantly trending upwards. LEVEL OF EVIDENCE: Level III.

Comparison of operative implications between adolescent and young adult idiopathic scoliosis patients from scoliosis research society mortality and morbidity database.

PURPOSE: To compare the operative implications between adolescent idiopathic scoliosis patients (10-18 years) and young adult idiopathic scoliosis (YAdIS) patients (19-30 years). METHODS: This was a retrospective study querying the SRS M&M database for AIS (10-18 years) and YAdIS (19-30 years) cases enrolled between 2009 and 2015. Demographic and surgical parameters (Lenke curve classification, preoperative curve magnitude, approach type, osteotomy type, estimated blood volume (EBV), levels of fusion and ASA scores) were evaluated and compared between groups. RESULTS: N = 690: AIS (n = 607) and YAdIS (n = 83). Lenke curve classification distributions in AIS and YAdIS cases were: main thoracic, 293 vs. 34; double thoracic, 42 vs. 5; double major, 159 vs. 15; triple major, 15 vs. 5; thoracolumbar, 85 vs. 17; and lumbar, 5 vs. 6, respectively. Patients with a coronal curve > 90° were significantly greater in YAdIS vs. AIS patients, p = 0.008. Anterior and combined surgery rates were significantly higher in YAdIS, p = 0.028. Two-staged surgeries were significantly higher for YAdIS cohort, p = 0.01. Osteotomy rate was similar between groups, p = 0.42, but proportion of 3-column osteotomies was significantly higher for YAdIS, p < 0.001. ASA (severe systemic disease and some functional limitation) score 3 patients' rate was higher in YAdIS cohort, p = 0.01. EBV was significantly higher in YAdIS, p = 0.01. Average number of levels of fusions between cohorts was not significant, p = 0.87. CONCLUSIONS: The operative implications observed with young adult idiopathic scoliosis patients may potentially result in more complex surgical procedures and operative-associated complications than their adolescent counterparts. Further studies are required and should include a larger number of cases, be prospective in nature and verifiable data. LEVEL OF EVIDENCE: II.

The Reliability of CT Scan Measurements of Pelvic Incidence in the Evaluation of Adult Spondylolisthesis.

BACKGROUND:  Pelvic incidence (PI) has been described as a parameter that may be a risk factor for lumbar spondylolisthesis (SPL). Studies have reported PI measurement is more precise in CT scans. Very limited studies have measured PI using CT scans to evaluate SPL. We analyzed the reliability of CT scans to measure PI to evaluate SPL and compared it to patients without SPL. METHODS:  A retrospective, cross-sectional study of PI in a consecutive cohort of patients' pelvic/abdominal CT scans from an emergency room visit at a Level 1 trauma center between 2013 and 2016. Inclusion criteria was >18 years and had no lumbar or pelvis fracture. A total of 361 patients met the criteria for our study. We documented age, average PI, and SPL (type, grading, and location). Sagittal CT scans were used to measure PI (between hip axis to an orthogonal line originating at the center of superior end plate axis of first sacral vertebra). Patients were categorized: with SPL (n=45) and without SPL (n=316). Subgroups were comprised based on the location of SPL (L4/L5 and L5/S1) and type of SPL. Analysis of variance (ANOVA) and chi-square tests used; p≤0.05 considered statistically significant. RESULTS:  Patients with SPL were significantly older versus patients without SPL, p=0.006. There were no statistical differences in PI between patients with and without SPL (p=0.29); between subgroups of patients with SPL at L4/L5 and without SPL (p=0.52); between subgroups with type of SPL at L4/L5 and without SPL (p=0.47); and between SPL patients at L5/S1 and without SPL (p=0.40). Patients with isthmic SPL at L5/S1 had nearly significant higher PIs (p=0.06) compared to those without SPL or with degenerative SPL at L5/S1. There was a trend towards higher PI in Grade 2 SPL patients at L5/S1, p=0.18. CONCLUSIONS: Patients with SPL were significantly older than patients without SPL. The two trends observed were that PI was higher in patients with isthmic SPL at L5/S1 and an increased PI with Grade 2 isthmic SPL at L5/S1. Our reported CT PI measurements correlated with reported PI measured using standard radiographs in patients with SPL. CT scans may be a reliable modality to evaluate adult SPL.

Evaluation of shoulder balance in early onset scoliosis after definitive fusion and comparison with adolescent idiopathic scoliosis shoulder balance.

STUDY DESIGN: The Children Spine Study Group registry was queried for early onset scoliosis (EOS) patients who had final definitive spinal fusion after their scoliosis was managed with either growing rods or VEPTR. The Harms Study Group registry was queried for adolescent idiopathic scoliosis (AIS) patients who had definitive fusion OBJECTIVE: The goal is to assess shoulder alignment in EOS patients after a definitive fusion and how these radiographic outcomes relate to the more familiar situation of post-definitive fusions shoulder alignment in AIS patients. BACKGROUND: EOS is a challenging pathology to manage. Numerous components are important in the success of spinal surgery for this population. Shoulder balance is a one of the components that is easily seen by the patient. Recently, the importance of its relationship to patient satisfaction has received greater attention. METHODS: Sample size: n = 145 (EOS (n = 34) and AIS (n = 111)). Shoulder balance parameters (SBP) of clavicular angle (CA), coracoid height difference (CHD), clavicular tilt angle difference (CTAD), and clavicle-rib cage intersection difference (CRID) measurements were measured from the reviewed radiographs and documented pre-definitive, post-definitive and 2-year follow-up measures. Shoulder balance parameters were compared between EOS and AIS cohorts at documented intervals. RESULTS: EOS mean pre-definitive fusion SBPs (CA, CTAD, CRID, CHD) were significantly higher compared to AIS, p = 0.004, 0.003, < 0.001, < 0.001, respectively. Significant post-definitive fusion corrections were noticed for CTAD (0.01), CHD (0.01), nearly significant CA (0.07), non-significant CRID in EOS patients. In AIS patients, no significant corrections were noticed for CA, CTAD, CHD and but significant for CRID (0.02). At post-definitive and 2-year follow-up, CA, CRID, CHD were not significant between cohorts, but CTAD (< 0.01) was significantly higher in EOS cohort at final follow-up. CONCLUSION: Post-definitive and 2-year follow-up shoulder balance for EOS patients was not significantly different from AIS patients. LEVEL OF EVIDENCE: III.

Impact of liberal intraoperative allogeneic blood transfusion on postoperative morbidity and mortality in major thoracic and lumbar posterior spine instrumentation surgeries.

PURPOSE: To investigate the impact of intraoperative blood transfusion on outcomes in patients who had major thoracic and lumber posterior spine instrumentation surgery. METHODS: Retrospective study included patients who underwent major spine surgery between 2013 and 2017. Patients' demographics, surgical charts, anesthesia charts, discharge charts and follow-up outpatient charts were reviewed. Data collection included: age, gender, BMI, Charlson Co-morbidity Index (CCI) scores, American Society of Anesthesiologists (ASA) scores, amount of estimated blood loss [% estimated blood volume (%EBV)], amount of blood transfused during surgery and post-surgery before discharge, number of fusion levels, pre- and postoperative hemoglobin (Hb) levels, and length of hospital stay. Also collected in-hospital postoperative complications (cardiovascular, pulmonary, infections and deaths). Patients' postoperative intubation status data documented. Reviewed follow-up charts to document any complications. RESULTS: Sample size = 289; No transfusion = 92; transfusion = 197. Transfused patients were significantly older, p < 0.001, higher average BMIs (p < 0.001); ASA scores (p < 0.001); CCI scores (p < 0.001), mean postoperative Hb level (p = 0.004), average intraoperative %EBV loss (p < 0.001), longer hospital stays (p = 0.003). Non-transfusion cohort had significantly higher proportion of patients (p < 0.001) extubated immediately after surgery. Seventeen patients had at least one in-hospital complication, p = 0.05. Complications were not significant among groups. CONCLUSION: Intraoperative blood transfusions and high volume intraoperative allogeneic blood transfusions did not increase risk for in-hospital complications or surgical site infections. Delayed extubations noticed in patients who received higher volumes of intraoperative allogeneic blood transfusions. High-volume intraoperative blood transfusions increased length of hospital stays. High post-hospital surgical infections associated with high volume intraoperative blood transfusions. Results should be interpreted cautiously due to small sample size.

Distal Ventral Iliac Pathway for Spinopelvic Fixation: Technique Description and Case Series.

BACKGROUND: Pelvic fixation improves the stability of spinal instrumentation and can be used in high-grade degenerative disease, trauma, deformity, and destabilizing invasive pathologies, such as infection and tumor. Classic techniques for spinopelvic fixation include traditional iliac screws and S2-Alar-Iliac screws. We present a case series describing the distal ventral iliac pathway (DVIP) for spinopelvic fixation and discuss surgical indications and merits of this technique. We describe the use of the DVIP for spinopelvic fixation in the setting of degenerative and traumatic pathologies, compare this technique with existing approaches, and summarize literature to support this approach. METHODS: One hundred twenty-eight cases of DVIP screws were identified at 1 academic medical center, and 3 cases were chosen as representative examples for technique demonstration. RESULTS: Patient ages ranged from 19 to 81 (mean 62) years. Intraoperative and postoperative complications include 12 incidental durotomies, 3 suprafascial infections, and 2 compressive hematomas. There were 22 instances of hardware failure and 8 instances of pseudoarthrosis. Overall, 26 patients underwent revision surgery. Mean estimated blood loss, operative time, and time under fluoroscopy were 1959 mL, 386 minutes, and 3.19 minutes, respectively. CONCLUSIONS: The DVIP is both safe and effective as a treatment for patients with degenerative and traumatic lumbosacral pathology. Spinopelvic fixation provides improved soft tissue coverage and fewer hardware complications at minimum of 1 year follow up. This case series demonstrates a novel surgical technique for spinopelvic fixation in the setting of numerous spinal pathologies. LEVEL OF EVIDENCE: 4. CLINICAL RELEVANCE: This surgical technique is less technically challenging than current approaches, minimizes radiation exposure, and obviates the need for horizontal connector rods. In addition, in highly destabilizing pathologies, this technique also allows for multiple screw placement within the ilium, while maintaining the ability to connect to a single rod construct. This technique is safe, technically approachable, and broadly applicable to an array of spinopelvic pathologies.

Harmonized outcome measures for use in degenerative lumbar spondylolisthesis patient registries and clinical practice.

OBJECTIVE: The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS: Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality's Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS: The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS: This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

Is it safe to stop at C7 during multilevel posterior cervical decompression and fusion? - multicenter analysis.

BACKGROUND CONTEXT: Despite a number of studies addressing the anatomical and biomechanical challenges of long segment, posterior cervical fusion surgery, recommendations for appropriate caudal "end level" vary widely. PURPOSE: Compare revision rates, patient reported outcomes and radiographic outcomes in patients in whom 3+ level posterior fusions ended in the cervical spine versus those in whom the fusion was extended into the thoracic spine. STUDY DESIGN: Multicenter retrospective analysis. OUTCOME MEASURES: Visual analog scale (VAS), Oswestry disability index (ODI), cervical lordosis, C2-C7 sagittal plumbline, T1 slope, and revision rate. METHODS: We assembled a radiographic and clinical database of patients that had undergone three or more level posterior cervical fusions for degenerative disease from January 2013 to May 2015 at one of four busy spine centers. Only those patients with at least 2 years of postoperative (postop) follow-up were included. Patients were divided into two groups: group I (fusion ending at C6 or C7) and group II (fusion extending into the thoracic spine). All radiographic measurements (cervical lordosis, T1 slope, and C2-C7 sagittal plumbline) were performed by an independent experienced clinical researcher. RESULTS: Two hundred and sixty-four patient cases were reviewed and sorted into the two outlined groups, Group I (n=168) and Group II (n=96). Demographically, mean age, percentage of females, non-smokers and anterior support were greater in Group II than in Groups I (p<.05). Mean estimated blood loss (EBL), operative time (OR) and length of hospital stay (LOS) were significantly higher in Group II (p<.05). Rate of revision was not clinically or statistically significantly different (p>.05) between Group I (11.1%) and Group II (9.4%). The majority of the revision surgeries occurred between 2 to 5 years postop. A greater number of subjacent degeneration/spondylolisthesis events were noted in Group I compared with Group II (3.6% vs. 1.2%). There were significant improvements in mean clinical outcomes (ie, VAS and ODI) at two years postop in both groups, but there were no statistically significant differences between the groups (p>.05). Mean cervical lordosis at 2 years postop improved in all groups (12.8° vs. 14.1°); however, there was no significant statistical difference in change for mean cervical lordosis (2 weeks vs. 2 year postop) between the two groups. Similary, there were no significant statistical differences in change for mean C2-C7 sagittal plumbline and T1 slope (2 weeks vs. 2 year postop) between the two groups(p>.05). CONCLUSIONS: Caudal end level did not significantly affect revision rates, patient reported outcomes or radiographic outcomes. Higher EBL, OR, and LOS in group II suggest that, absent focal C7-T1 pathology, extension of posterior cervical fusions into the thoracic spine may not be necessary. Extension of posterior cervical fusions into the thoracic spine may be recommended for higher risk patients with limitations to strong C7 bone anchorage. In others, it is safe to stop at C7.

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series. PURPOSE: To evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy. STUDY DESIGN/SETTING: Prospective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF. OUTCOME MEASURES: Pain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months. METHODS: Using propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls). RESULTS: Both ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups. CONCLUSIONS: M6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.

Comparison of adverse events between cervical disc arthroplasty and anterior cervical discectomy and fusion: a 10-year follow-up.

BACKGROUND CONTEXT: Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported. PURPOSE: To investigate the 10-year follow-up adverse events rates between CDA and ACDF. STUDY DESIGN/SETTING: The study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a postapproval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004. PATIENT SAMPLE: n=463 patients. OUTCOME MEASURES: Adverse events comparison of CDA and ACDF from self-reported and physiologic measures. METHODS: At each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups. RESULTS: A total of 242 patients received CDA and 221 patients received ACDF. At 10-year follow-up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p=.012) and more spinal events at the index level (p=.006). The ACDF group had significantly more nonunion events (p=.019), and nonunion outcome pending (p=.034), adjacent level spinal events (p=.033), and events that fell into the "other" category (p=.015). CONCLUSIONS: The cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.

Outcomes of Negative Pressure Wound Therapies in the Management of Spine Surgical Site Wound Infections.

BACKGROUND: Many studies report benefits using negative pressure wound therapy (NPWT) in surgical site infections (SSIs). We measured and compared efficacy and complications associated with NPWT for traditional versus suprafascial vacuum-assisted closures (VACs). METHODS: This is a retrospective chart review of consecutive SSIs managed with negative wound therapy after spinal procedures between 2012 and 2015 from a single, academic center. Patients were collected through International Classification of Diseases, Ninth Revision, procedure codes. Inclusion criteria were patients with spine SSIs managed by irrigation and debridement with a VAC device; infection occurring after spinal surgeries; and age over 18. A total of 23 consecutive patients met the criteria. We reviewed demographic data, surgical data, infectious disease data, discharge summaries, and postoperative follow-up charts. We compared and analyzed demographics, duration of VAC therapy, and reoperation rates between VAC groups. Statistical analysis was completed using analysis of variance and χ2 tests; P ≤ 0.05 was considered statistically significant. RESULTS: A total of 7 patients had traditional VACs (Group 1), and 16 patients had suprafascial VACs (Group 2). Average blood loss and number of levels involved during index surgery were not statistically significant between groups. Locations of infection occurrence were cervical spine = 3, thoracic spine = 1, and lumbar spine = 19. Reoperation rate after initial wound VAC placement was 34%, with rates significantly higher for Group 1 (71%) than Group 2 (16%), P = 0.02. Average duration of wound therapy was longer in Group 1 (77 days) than Group 2 (33 days), P = 0.08. Average number of operating room visits after initial wound VAC implantation were 0.7 for Group 1 and 0.3 for Group 2, P = 0.26, before obtaining a clean wound closure. CONCLUSIONS: Small sample size and retrospective nature were limitations. Negative pressure wound therapy may be useful for managing spinal infections, and suprafascial VAC had less time duration, lower risk of sponge fragment retainment, and fewer procedures to ultimately achieve wound closure. LEVEL OF EVIDENCE: 3.